EUCTR2018-000202-37-GBActive, not recruitingPhase 1
A Phase 3b Open-label Study of the Anti-FGF23 Antibody, Burosumab (KRN23) in Adult Patients with X-linked Hypophosphatemia (XLH)
Kyowa Kirin Pharmaceutical Development Ltd0 sites40 target enrollmentStarted: April 30, 2019Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1) Subjects who provide written informed consent after the nature of the study has been
- •explained, and prior to any research-related procedures.
- •2) Subject who successfully completed Study UX023-CL303 or UX023-CL304. Subjects should have completed the study up to and including the final study visit.Subjects who were prematurely discontinued due to adverse events, Sponsor's decision or Investigator's decision will not be enrolled in this study. Subjects' enrolment is not dependent on any response to Primary or Secondary endpoints in studies UX023-CL303 or UX023CL304.or those which did not complete the studies for reasons other than serious adverse events or protocol deviations may be considered on a case by case basis.
- •3) Willing to provide access to prior medical records for the collection of historical growth,
- •biochemical and radiographic data, and disease history.
- •4) Must, in the opinion of the investigator, be willing and able to complete all aspects of the
- •study, adhere to the study visit schedule and comply with the assessments.
- •5) Females of child-bearing potential must have a negative urine pregnancy test at Screening and
- •be willing to have additional pregnancy tests during the study. Females considered not to be of
- •child-bearing potential include those who have been in menopause for at least two years prior
- •to Screening, or have had tubal ligation at least one year prior to Screening, or have had a total
- •hysterectomy or bilateral salpingo-oophorectomy. If sexually active, male and female subjects
- •must be willing to use one highly effective method of contraception for the duration of the
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •1) Hypocalcemia or hypercalcemia, defined as serum calcium levels outside the age-adjusted
- •normal limits and deemed as clinically significant in the opinion of the investigator.
- •2) Presence of a concurrent disease or condition that would interfere with study participation
- •or affect safety in the opinion of the investigator or Sponsor.
- •3) Use of any investigational product other than burosumab or investigational medical device
- •within 30 days prior to Screening, or requirement for any investigational agent prior to
- •completion of all scheduled study assessments.
- •4) Subjects with major protocol deviations in Study UX023-CL303 or UX023-CL304 which
- •in the view of the investigator places the subject at high risk of poor treatment compliance or of not completing the study. Or higher than a grade 3 treatment related hypersensitivity reaction or burosumab related hypersensitivity reaction reported as a SAE will be excluded.
Investigators
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